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Gemcitabine Combined With Mistletoe in Treating Patients With Advanced Solid Tumors

Primary Purpose

Breast Cancer, Colorectal Cancer, Lung Cancer

Status
Terminated
Phase
Phase 1
Locations
United States
Study Type
Interventional
Intervention
mistletoe extract
gemcitabine hydrochloride
Sponsored by
National Center for Complementary and Integrative Health (NCCIH)
About
Eligibility
Locations
Outcomes
Full info

About this trial

This is an interventional treatment trial for Breast Cancer focused on measuring male breast cancer, recurrent breast cancer, recurrent colon cancer, recurrent non-small cell lung cancer, recurrent pancreatic cancer, recurrent rectal cancer, stage III colon cancer, stage III pancreatic cancer, stage III rectal cancer, stage IIIA breast cancer, stage IIIB breast cancer, stage IIIC breast cancer, stage IV breast cancer, stage IV colon cancer, stage IV non-small cell lung cancer, stage IV rectal cancer, stage IIIA non-small cell lung cancer, stage IIIB non-small cell lung cancer, stage IV pancreatic cancer

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

DISEASE CHARACTERISTICS: Histologically confirmed metastatic, recurrent, or unresectable locally advanced solid tumor, including one of the following: Breast or colorectal cancer that has failed first-line chemotherapy Non-small cell lung cancer Pancreatic Cancer No CNS metastases Hormone receptor status: Not specified PATIENT CHARACTERISTICS: Age 18 and over Sex Male or female Menopausal status Not specified Performance status ECOG 0-1 Life expectancy Not specified Hematopoietic Absolute neutrophil count at least 1,500/mm^3 Platelet count at least 100,000/mm^3 Hepatic Bilirubin no greater than 2.0 mg/dL No clinically significant hepatic dysfunction Renal Creatinine no greater than 2.5 mg/dL No clinically significant renal dysfunction Other Not pregnant or nursing Negative pregnancy test HIV negative No clinically significant unrelated illness (e.g., serious infection or organ dysfunction) that would preclude study tolerance PRIOR CONCURRENT THERAPY: Biologic therapy No prior mistletoe Chemotherapy See Disease Characteristics No prior gemcitabine More than 30 days since prior chemotherapy and recovered Endocrine therapy More than 30 days since prior glucocorticosteroid therapy Radiotherapy Recovered from prior radiotherapy Surgery Recovered from prior surgery Other At least 30 days since prior investigational agents No other concurrent investigational agents

Sites / Locations

  • Warren Grant Magnuson Clinical Center - NCI Clinical Trials Referral Office

Outcomes

Primary Outcome Measures

Secondary Outcome Measures

Full Information

First Posted
November 12, 2002
Last Updated
June 17, 2013
Sponsor
National Center for Complementary and Integrative Health (NCCIH)
Collaborators
National Cancer Institute (NCI)
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1. Study Identification

Unique Protocol Identification Number
NCT00049608
Brief Title
Gemcitabine Combined With Mistletoe in Treating Patients With Advanced Solid Tumors
Official Title
A Phase I Study Of The Effect Of Mistletoe Extract, A Complementary Medicine Botanical, On Pharmacokinetics, Pharmacodynamics And Safety Of Gemcitabine In Patients With Advanced Solid Tumors
Study Type
Interventional

2. Study Status

Record Verification Date
April 2007
Overall Recruitment Status
Terminated
Why Stopped
Principal investigator [PI] has left institution.
Study Start Date
July 2002 (undefined)
Primary Completion Date
undefined (undefined)
Study Completion Date
August 2011 (Actual)

3. Sponsor/Collaborators

Name of the Sponsor
National Center for Complementary and Integrative Health (NCCIH)
Collaborators
National Cancer Institute (NCI)

4. Oversight

5. Study Description

Brief Summary
RATIONALE: Drugs used in chemotherapy, such as gemcitabine, use different ways to stop tumor cells from dividing so they stop growing or die. Mistletoe may slow the growth of tumor cells and may be an effective treatment for solid tumors. PURPOSE: Phase I trial to study the effectiveness of combining gemcitabine with mistletoe in treating patients who have advanced solid tumors.
Detailed Description
OBJECTIVES: Determine the maximum tolerated dose of gemcitabine and mistletoe in patients with advanced solid tumors. Determine the toxic effects of this regimen in these patients. Determine the pharmacokinetic effects of gemcitabine with and without mistletoe in these patients. Determine tumor response in patients treated with this regimen. Determine the time to neutrophil count recovery in patients treated with this regimen. OUTLINE: This is an open-label, dose-escalation study. Patients receive gemcitabine IV over 30 minutes on days 1 and 8 and mistletoe subcutaneously daily starting on day 8 of course 1. Treatment repeats every 21 days for at least 3 courses in the absence of disease progression or unacceptable toxicity. Patients receive escalating doses of gemcitabine and mistletoe in 2 stages. Stage I: Cohorts of 3-6 patients receive escalating doses of mistletoe in combination with a constant dose of gemcitabine until the maximum tolerated dose (MTD) of mistletoe is determined. Stage II: Cohorts of 3-6 patients receive escalating doses of gemcitabine in combination with the MTD of mistletoe as determined in stage I until the MTD of gemcitabine is determined. In both stages, the MTD is defined as the dose preceding that at which 2 patients experience dose-limiting toxicity. PROJECTED ACCRUAL: A total of 45-51 patients will be accrued for this study.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Breast Cancer, Colorectal Cancer, Lung Cancer, Pancreatic Cancer
Keywords
male breast cancer, recurrent breast cancer, recurrent colon cancer, recurrent non-small cell lung cancer, recurrent pancreatic cancer, recurrent rectal cancer, stage III colon cancer, stage III pancreatic cancer, stage III rectal cancer, stage IIIA breast cancer, stage IIIB breast cancer, stage IIIC breast cancer, stage IV breast cancer, stage IV colon cancer, stage IV non-small cell lung cancer, stage IV rectal cancer, stage IIIA non-small cell lung cancer, stage IIIB non-small cell lung cancer, stage IV pancreatic cancer

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 1
Masking
None (Open Label)
Enrollment
51 (Anticipated)

8. Arms, Groups, and Interventions

Intervention Type
Dietary Supplement
Intervention Name(s)
mistletoe extract
Intervention Type
Drug
Intervention Name(s)
gemcitabine hydrochloride

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
DISEASE CHARACTERISTICS: Histologically confirmed metastatic, recurrent, or unresectable locally advanced solid tumor, including one of the following: Breast or colorectal cancer that has failed first-line chemotherapy Non-small cell lung cancer Pancreatic Cancer No CNS metastases Hormone receptor status: Not specified PATIENT CHARACTERISTICS: Age 18 and over Sex Male or female Menopausal status Not specified Performance status ECOG 0-1 Life expectancy Not specified Hematopoietic Absolute neutrophil count at least 1,500/mm^3 Platelet count at least 100,000/mm^3 Hepatic Bilirubin no greater than 2.0 mg/dL No clinically significant hepatic dysfunction Renal Creatinine no greater than 2.5 mg/dL No clinically significant renal dysfunction Other Not pregnant or nursing Negative pregnancy test HIV negative No clinically significant unrelated illness (e.g., serious infection or organ dysfunction) that would preclude study tolerance PRIOR CONCURRENT THERAPY: Biologic therapy No prior mistletoe Chemotherapy See Disease Characteristics No prior gemcitabine More than 30 days since prior chemotherapy and recovered Endocrine therapy More than 30 days since prior glucocorticosteroid therapy Radiotherapy Recovered from prior radiotherapy Surgery Recovered from prior surgery Other At least 30 days since prior investigational agents No other concurrent investigational agents
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Patrick J. Mansky, MD
Organizational Affiliation
National Center for Complementary and Integrative Health (NCCIH)
Official's Role
Principal Investigator
Facility Information:
Facility Name
Warren Grant Magnuson Clinical Center - NCI Clinical Trials Referral Office
City
Bethesda
State/Province
Maryland
ZIP/Postal Code
20892
Country
United States

12. IPD Sharing Statement

Citations:
PubMed Identifier
24285980
Citation
Mansky PJ, Wallerstedt DB, Sannes TS, Stagl J, Johnson LL, Blackman MR, Grem JL, Swain SM, Monahan BP. NCCAM/NCI Phase 1 Study of Mistletoe Extract and Gemcitabine in Patients with Advanced Solid Tumors. Evid Based Complement Alternat Med. 2013;2013:964592. doi: 10.1155/2013/964592. Epub 2013 Oct 27. Erratum In: Evid Based Complement Alternat Med. 2014;2014:606348.
Results Reference
result

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Gemcitabine Combined With Mistletoe in Treating Patients With Advanced Solid Tumors

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